| CTRI Number |
CTRI/2025/11/097933 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing yoga therapy and usual medical treatment to see which helps women with PCOS ovulate better |
|
Scientific Title of Study
|
Comparison of Yoga-Integrated Therapy and Standard Medical Management on
Ovulation Outcomes in Women with Polycystic Ovary Syndrome: A Randomised
Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sommya Naberia |
| Designation |
POST GRADUATE RESIDENT,Obs & Gynae department |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Obs & gynae department ,Gynae office,ground floor purani building,near hospital kitchen
Lady Hardinge Medical College Connaught Place
New Delhi
DELHI
110001
India |
| Phone |
6264889011 |
| Fax |
|
| Email |
sommyayaya@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pikee Saxena |
| Designation |
Director Professor,Head of Unit |
| Affiliation |
GYNAECOLOGY OPD AND INFERTILITY OPD LADY HARDINGE MEDICAL COLLEGE |
| Address |
Obs&Gynae department,
room no 413
4th floor old building
Near Hospital kitchen
Lady Hardinge Medical College
Connaught Place
New Delhi
DELHI
110001
India |
| Phone |
09868223323 |
| Fax |
|
| Email |
pikeesaxena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Singh |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Obs& Gynae department
3rd floor Porta Cabin
Old Building
near hospital kitchen
Lady Hardinge Medical College Connaught Place New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9560511155 |
| Fax |
|
| Email |
drmeenakshisingh99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sommya Naberia |
| Address |
Obs&Gynae department
gynae office ground floor near hospital kitchen
Purani building
Lady Hardinge Medical College
Connaught Place
New Delhi pincode 110001 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sommya Naberia |
Lady Hardinge Medical College |
Department of Obstetrics and gynaecology
Infertility OPD , Room 120
Connaught place
New Delhi
DELHI |
9205755665
sommyayaya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committee for Human Research Lady Hardinge Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard medical management for infertile women with PCOS |
GROUP-B: Control group
50 Infertile Females with PCOS will be advised lifestyle management for a period of 6weeks and then will be
started with ovulation induction by letrozole for 3 months alongside lifestyle advice for 12 weeks |
| Intervention |
Yoga Integrated Therapy for infertile women with PCOS
|
Group-A
INTERVENTION GROUP
50 Infertile Females with PCOS will be exposed to Yoga Therapy for 6 weeks followed by standard medical
treatment alongside yoga therapy for 3months. During the first 6 weeks the subjects will practice Yoga
regularly for 5 days a week. During the next 12 weeks i.e. the 3months period subjects will practice Yoga
twice a week on Mondays and Thursdays in OPD and for remaining days at home & will be given ovulation
induction by letrozole for 3 months for the same duration.
Participants will be monitored on weekly basis through the phone & videos calls and by maintaining a separate
participant diary for keeping a track of no. of sessions attended.
Session length – 45-50min
Home sessions monitored by video calls under supervision of yoga therapists on remaining days of the week
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
Infertile women aged between 19 and 38 years & diagnosed with PCOS as per Rotterdam Criteria
Willingness and ability to participate in the structured yoga intervention program for the entire study
duration.
Possession of a smartphone with internet access for regular follow-up reminders and compliance
monitoring
Willingness to comply with study procedures, including regular attendance at yoga sessions and follow up visits |
|
| ExclusionCriteria |
| Details |
Known cases of chronic systemic illnesses, such as cerebrovascular diseases, thyroid disorders
cardiovascular diseases, or any other severe systemic illness & physical disorders that would interfere with
study participation or compliance
Presence of tubal factor and/or male factor infertility and poor ovarian reserve
Women who have received ovulation induction drugs within the last three months prior to recruitment
History of recurrent pregnancy loss, defined as two or more consecutive spontaneous miscarriages
Prior regular practice of structured physical exercise programs, example regular workouts or yoga or
meditation within the last six months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME:
OUTCOME VARIABLES:
Proportion of infertile women with PCOS who ovulate in two groups receiving structured yoga plus standard
treatment versus standard treatment alone using TVUS follicular monitoring and Day-21 Progesterone levels |
At baseline and after 12weeks period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Menstrual Cycle changes
Cardiometabolic parameter changes
hormone profile changes
mental health & quality of life parameters changes |
At baseline & after 12weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 10-11-2026 and end date provided 06-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Polycystic ovarian syndrome being an endocrine disorder is the most common cause for infertility in reproductive age females While pharmacological therapies for PCOS primarily focus on ovulation induction they often fall short in addressing the broader metabolic and emotional needs YIT offers a holistic alternative that targets these multifaceted concerns Evidence suggests that yoga can improve insulin sensitivity regulate hormonal imbalances reduce stress improve cardiometabolic outcomes and enhance overall wellbeing factors that are directly implicated in the pathology of PCOS There is a paucity of data evaluating yoga as an adjunct therapy to improve ovulation rates in infertile women with PCOS while also addressing metabolic, hormonal, and psychological health in infertile Indian women. This study aims to fill that gap by assessing the effectiveness of structured yoga intervention alongside standard treatment providing a cost effective holistic approach for improving ovulation rates in Indian infertile females with PCOS |